IntelliSep Sepsis Test

JSON twin: https://www.healthaidb.com/software/intellisep-sepsis-test.json

Company Name

Cytovale

Product URL

https://cytovale.com/our-solution/intellisep-sepsis-test/

Company URL

https://cytovale.com

Categories

• diagnostic Support
• clinical Care
• patient Facing
• Diagnostic
• Clinical

Summary

IntelliSep Sepsis Test is a rapid diagnostic tool developed by Cytovale to aid in the early detection and risk stratification of sepsis in emergency department patients, delivering actionable results in approximately 8 minutes.

Description

IntelliSep Sepsis Test is an FDA-cleared in vitro diagnostic device designed to assess the risk of sepsis in adult patients presenting with signs and symptoms of infection in the emergency department. Utilizing a host response approach, it analyzes biophysical changes in white blood cells to detect sepsis due to any pathogen. The test provides results in about 8 minutes, stratifying patients into three bands based on their probability of having sepsis, thereby facilitating timely diagnosis and treatment decisions.

Api Available

unknown

Certifications

• FDA 510(k) clearance

Company Founding

2016

Company Offices

• United States

Compliance

• FDA 510(k) clearance
• HIPAA
• SOC 2
• ISO 27001

Customers

Data Residency

US-only

Data Standards

• HL7 v2

Deployment Model

• on_prem

Features

• FDA-cleared in vitro diagnostic test for sepsis
• Rapid results in approximately 8 minutes
• Risk stratification based on sepsis probability score
• Pathogen-agnostic detection of sepsis
• Utilizes standard 100 µL blood sample from 'purple-top' K2 EDTA tube
• Seamless integration with laboratory information systems (LIS)
• No calibration required
• No vacuum or plumbing required
• Compact system requiring 4 ft bench space
• Quarterly preventive maintenance (PM)

Id

SW1199

Integration Partners

Integrations

• Laboratory Information Systems (LIS)

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• BAA available
• Data anonymization
• Data minimization

Product Code

SW1199

Product Name

IntelliSep Sepsis Test

Ratings

Regions Available

• United States

Related Urls

• https://elion.health/products/cytovale-intellisep

Release Year

Security Features

• Encryption
• Audit logs
• Cybersecurity compliance assistance

Specialties

• Emergency Medicine

Support Channels

System Requirements

Windows, Linux

Target Users

• clinicians
• nurses
• patients
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "IntelliSep Sepsis Test",
  "company_name": "Cytovale",
  "product_url": "https://cytovale.com/our-solution/intellisep-sepsis-test/",
  "company_url": "https://cytovale.com",
  "related_urls": [
    "https://elion.health/products/cytovale-intellisep"
  ],
  "product_code": "SW1199",
  "summary": "IntelliSep Sepsis Test is a rapid diagnostic tool developed by Cytovale to aid in the early detection and risk stratification of sepsis in emergency department patients, delivering actionable results in approximately 8 minutes.",
  "description": "IntelliSep Sepsis Test is an FDA-cleared in vitro diagnostic device designed to assess the risk of sepsis in adult patients presenting with signs and symptoms of infection in the emergency department. Utilizing a host response approach, it analyzes biophysical changes in white blood cells to detect sepsis due to any pathogen. The test provides results in about 8 minutes, stratifying patients into three bands based on their probability of having sepsis, thereby facilitating timely diagnosis and treatment decisions.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "patient Facing",
    "Diagnostic",
    "Clinical",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "nurses",
    "patients",
    "admins"
  ],
  "specialties": [
    "Emergency Medicine"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2016",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Windows",
    "Linux"
  ],
  "features": [
    "FDA-cleared in vitro diagnostic test for sepsis",
    "Rapid results in approximately 8 minutes",
    "Risk stratification based on sepsis probability score",
    "Pathogen-agnostic detection of sepsis",
    "Utilizes standard 100 µL blood sample from 'purple-top' K2 EDTA tube",
    "Seamless integration with laboratory information systems (LIS)",
    "No calibration required",
    "No vacuum or plumbing required",
    "Compact system requiring 4 ft bench space",
    "Quarterly preventive maintenance (PM)"
  ],
  "optional_modules": [],
  "integrations": [
    "Laboratory Information Systems (LIS)"
  ],
  "data_standards": [
    "HL7 v2"
  ],
  "api_available": "unknown",
  "system_requirements": "Windows, Linux",
  "compliance": [
    "FDA 510(k) clearance",
    "HIPAA",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k) clearance"
  ],
  "security_features": [
    "Encryption",
    "Audit logs",
    "Cybersecurity compliance assistance"
  ],
  "privacy_features": [
    "BAA available",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW1199",
  "slug": "intellisep-sepsis-test",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/intellisep-sepsis-test.json"
  }
}